FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SELOFIX
K Number: K821257
·
Decision May 14, 1982
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
7
Review Days
14
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Basic Information
- Device Name
- SELOFIX
- K Number
- K821257
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Selomas, Inc.
- Date Received
- April 30, 1982
- Decision Date
- May 14, 1982
- Product Code
- KGX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
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CARE BAND ANTIBACTERIAL BANDAGES
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SYVEK PATCH
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ADHESIVE BANDAGES WITH OTC DRUG
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TARGETT PATCH
FDA 510(k)
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PARALLEL
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Selomas, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861215 | GAUZE SPONGES USP TYPE VII | Apr 17, 1986 | Substantially Equivalent |
| K821258 | SELOPOR | Aug 19, 1982 | Substantially Equivalent |
| K821260 | VITOFIT | Jun 23, 1982 | Substantially Equivalent |
| K821259 | VITASAN | Jun 23, 1982 | Substantially Equivalent |
| K821490 | SILKAFIX ADHESIVE PLASTER | Jun 2, 1982 | Substantially Equivalent |
| K812501 | OPRAFLEX | Oct 2, 1981 | Substantially Equivalent |